Lana Keeton was 54 when a surgeon used a synthetic mesh to
createa pubovaginal sling to treat her for
stress urinary incontinence.After her surgery in
2001, Ms Keeton developed a necrotizingsoft
tissue infection at the operative site. Surgeons laterfound that the mesh had migrated and eroded through
her bladderwall. During the past eight years, Ms
Keeton has had numerousprocedures and operations
to remove pieces of the mesh and totreat
recurrent urinary tract infections and pain. In October2008, the US Food and Drug Administration warned that
surgicalmeshes made by nine manufacturers,
including the manufacturerof the mesh implanted
in Ms Keeton, have been associated withserious
complications, including bowel and bladder perforations,infections, and pain.1 Because of a little
known loophole inthe device approval process,
the FDA did not require the manufacturersto
submit safety or efficacy data before receiving approval. . . [Full
text of this article]